Myth #1: Stem cells can cure almost every ailment

The misrepresentation of the therapeutic abilities of stem cells is quite common. Stem cells are not a “magic cure” for all diseases.  The long term therapeutic properties of stem cells are still being investigated, and although there have been many studies completed showing their positive effects on patients, results cannot always be guaranteed.  However, stem cell therapy is a viable treatment option for autoimmune conditions, chronic inflammation and a handful of other ailments.  

What can stem cell therapy potentially treat?

Stem cell therapy can potentially treat: 

• ALS
• Alzheimer’s
• Autoimmune conditions
• COPD
• Crohn’s Disease
• Diabetes (Type 1)
• Heart Failure
• Kidney Disease
• Liver Disease
• Lupus
• Lyme Disease
• Multiple Sclerosis
• Neurological conditions
• Neuropathy
• Parkinson’s
• Reflex Sympathetic Dystrophy (RSD)
• Spinal Cord Injury
• Stroke
• Traumatic Brain Injury (TBI)

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Myth #2: The United States offers the highest quality treatments

Despite the clinical evidence, the United States still has stringent regulations and laws against stem cell treatments. There may be many clinics in the US offering “stem cell therapies,” however, these treatments are highly restricted in scope and number of cells used. Some clinics within the United States may also attract new patients and then refer them to international clinics in Mexico or Central America, where regulations are much looser, and the source of the stem cells is unknown.  Conversely, there are also many international clinics pushing the envelope in stem cell research, cell quality and advanced therapy protocols. Some of these clinics are even holding patient-funded clinical studies.  These studies allow researchers to gain valuable insights into stem cell therapy and its potential to improve the disease state.  For example, DVC Stem, an advanced stem cell clinic located in Grand Cayman, is partnered with Vitro Biopharma, an award-winning medical laboratory located in Golden, Colorado, which is fully FDA registered, cGMP compliant, ISO 9001, and ISO 13485 certified. Their cells are only sourced from the American Association of Tissue Bank (AATB) certified suppliers of full-term, ethically US donated human umbilical cords. The selection of these donated tissues is exceptionally regulated and strict. Currently, US lawmakers have placed substantial limitations on stem cell applications.  These limitations have increased the popularity of medical tourism.   Patients are beginning to look elsewhere for life-changing treatments, including expanded allogeneic stem cell therapy.

Myth #3: All Stem cells are sourced unethically

One of the significant hurdles stem cell therapy has had to overcome the misconception that all stem cells are embryonic (sourced from a fetus). Embryonic stem cells are derived from human embryos and typically carry a negative moral status.  This negative view initially arose because human embryos are sourced from abortions, which are a culturally controversial practice.Today, most stem cells used in a clinical setting are derived from bone marrow, adipose or umbilical cord tissue. These forms of stem cells are not sourced from embryos and thus do not carry a negative moral connotation.  For example, Vitro Biopharma (DVC Stems partner lab) only uses the American Association of Tissue Bank (AATB) certified suppliers of full-term (>36 weeks), donated human umbilical cords. The selection of these donated tissues is exceptionally regulated and strict. The cords are tested for STDs, Hep A/B/C/D, TB, Zika virus, no history of cancer or chronic illness, no history of autoimmune diseases, no tattoos or piercings, no travel abroad with one year, no history of CJD, negative for HIV, negative for HTLV 1 AND 2, and no history of drug or alcohol abuse. After the tissue is vigorously screened and accepted, Vitro then uses its clinical-grade and award-winning proprietary culture medium to expand the stem cells out to roughly 300 million cells per treatment.

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Why use cord tissue-derived stem cells?

While other familiar sources of stem cells are fat tissue or bone marrow taken from the patient directly, there are many benefits to using cord tissue. Cord tissue-derived cells are necessarily “new,” in their most primal state, free from the effects of ageing or disease. Stem cells age as we age and cells taken from a patient are affected by the condition of the patient at the time of extraction. 

There is even evidence to suggest that cells extracted from patients with existing medical conditions risk reintroducing these symptoms when used in treatments. Cord tissue-derived stem cells eliminate that risk. Additionally, they are readily available, in high supply, and are minimally invasive to the patient, without the need for any extractions, free from immune rejection, and have zero risks of transferring viruses or other communicable diseases.

Myth #4: Umbilical cord tissue-derived stem cells do not contain “live cells”

The belief argues that umbilical cord tissue does not contain any live cells, whereas cells derived from bone marrow and adipose (fat tissue) do. This is a common misconception that some physicians in the United States may try to promote.  Umbilical cord tissue contains millions of undifferentiated live cells that have immense healing potential. The tissue found inside donated umbilical cords is called Wharton’s Jelly and contains millions of youthful, undifferentiated stem cells. Stem cells are grown in a cell media culture, which allows the cells to replicate and produce higher numbers over a few generations; this is called cell expansion. This process can turn a few million stem cells into billions, ready for use in treatments. Culturing and expansion of stem cells would not be possible if the cells extracted from the original cord tissue were not alive and active. Additionally, the cells used for treatment are tested for viability both before leaving the lab and just before treatment to ensure proper quality assurance standards are met.

Lab quality control is essential.

DVC Stem’s partner lab Vitro Biopharma rigorously tests cells for potency, blood-borne pathogens, contaminating agents, fungal presence, cellular ATP levels, and proper growth rates. The entire production process is completed in a certified sterile clean room, which must meet all regulations by the FDA, ISO, and CLIA. Once the cells are ready for use, they are held in sub-zero cryo-storage and shipped overnight to DVC Stem in the Cayman Islands for immediate use for a patient’s treatment.Additionally, the cells used for treatment are tested for viability both before leaving the lab and just before treatment to ensure proper quality assurance standards are met. Retaining cell viability during transportation from lab to clinic is an extremely delicate process that must be executed carefully from start to finish.     

Myth #5: Stem cells will not cross the blood-brain barrier

Stem cells are about 10-15 microns in size, smaller than white blood cells.  This allows the cells to pass through the blood-brain barrier when delivered via IV. Studies have shown exciting improvements in strength, coordination, motor skills, and mobility with Multiple Sclerosis patients.  These findings would not be possible if the cells were unable to access the nervous system. In layman's terms, stem cells mainly seek out areas of inflammation or damage, including nerves, and seek to repair or regenerate them.  The ability of stem cells to potentially regenerate neurons within the central nervous system and clinical findings supporting such strongly suggests that stem cells, when introduced via IV, can cross the blood-brain barrier.

In conclusion

As well as being essential to healthy human growth, stem cells are a potential source of new cells that can replace damaged or diseased tissue. These abilities that stem cells possess are what make them so promising in the treatment of various diseases and conditions.

References:

(1) Holland, S., Lebacqz, K. and Zoloth, L. (2019). The Human Embryonic Stem Cell Debate. [online] Google Books. Available at: https://books.google.com/books?hl=en&lr=&id=R1wV2pNTRfwC&oi=fnd&pg=PR11&dq=embryonic+stem+cells+controversy&ots=7IiaxVP7BG&sig=cBNPBWm8ICm73ijbdPSTt1UItdM#v=onepage&q=embryonic%20stem%20cells%20controversy&f=false [Accessed 31 Dec. 2019].

(2) Riordan, N. H., Morales, I., Fernández, G., Allen, N., Fearnot, N. E., Leckrone, M. E., … Paz Rodriguez, J. (2018, 9 Mar). Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/29523171.

(3) Levy, Michael L., et al. “Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke.” Stroke, vol. 50, no. 10, 2019, pp. 2835–2841., DOI:10.1161/strokeaha.119.026318.

(4) Shroff, Geeta. “Transplantation of Human Embryonic Stem Cells in Patients with Multiple Sclerosis and Lyme Disease.” The American Journal of Case Reports, International Scientific Literature, Inc., 13 Dec. 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC5156555/.

(5) Venkataramana, N. K., Kumar, S. K. V., Balaraju, S., Radhakrishnan, R. C., Bansal, A., Dixit, A., … Totey, S. M. (2009, 6 Aug). Open-labelled study of unilateral autologous bone-marrow-derived mesenchymal stem cell transplantation in Parkinson’s disease. Retrieved from https://www.sciencedirect.com/science/article/pii/S1931524409002205#!